In a presentation entitled ‘Biosimilar Considerations for Real World Research and Stakeholder Questions’ delivered at the Drug Information Association’s (DIA) Biosimilars Conference, which was held on 23‒24 September 2019 in Bethesda, Maryland, USA, Dr Jaclyn Bosco of IQVIA discussed the impact that biologicals have had on health care.
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Generics
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- FDA approves generic teriparatide and levetiracetam
- US generics launch and approval for Dr Reddy’s and Lupin
- Five Chinese companies join UN’s MPP for Covid-19 medicines
- South Korean companies to make generic Bridion and COVID-19 drugs
Research
- Japan’s drug shortage crisis: challenges and policy solutions
- Saudi FDA drug approvals and GMP inspections: trend analysis
- Generic medications in the Lebanese community: understanding and public perception
- Community pharmacists’ understanding of generic and biosimilar drugs: Lebanon case study
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Biosimilars
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- EC approves eight biosimilars, eight more await final authorization
- Canada approves first omalizumab biosimilar Omlyclo
- EMA recommends approval for tocilizumab biosimilar Avtozma and filgrastim biosimilar Zefylti
- Ustekinumab biosimilars Yesintek, Steqeyma, and Otulfi approved by FDA, EMA and Health Canada
Research
- Positive safety and efficacy primary endpoint results for AVT05 (golimumab proposed biosimilar)
- Are interchangeable biosimilars at risk?
- Comparative efficacy studies: where are we now?
- Pertuzumab biosimilar HLX11 meets primary endpoint in phase III comparative clinical study
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